ResponsibilitiesPlan, perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities. Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e.g., LIMS test activation and results entry). Accountable for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. 

ResponsibilitiesTo supervise compliance to all cGMP, GxP, or any other regulatory requirements, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Authorization of standard operation procedures and ensure its implementation. Handling of product recalls. Approval of annual product report. Report any quality concerns or suggestions for improvements to HOD. Execute and supervise all tasks and activities as per the applicable SOPs. Responsible to complete the assigned trainings, applicable for workgroup “Manufacturing-Manager-Goa” in the L2LMS. Overall responsibility to ensure effective and efficient manufacturing/packing operation to meet the sales and distribution requirements. To ensure that the Products are produced and stored in accordance to appropriate documentation to obtain required quality. To ensure preparation of all documents as & when required of production department and to approve instructions/documents related to production and ensure their strict implementation.Qualification & Experience10 - 15 years experience in manufacturing. Education Graduation in Pharmacy

ResponsibilitiesPerforming and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals. Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals. Good Laboratory Practice Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Reviewing pharmacopeias for specification preparation. Preparing SOPs, Formats, Specification, Analytical Test Record and other documents. Managing reference standards, working standards, Laboratory chemicals & reagents. Managing instrument laboratory with reference to spares, maintenance etc. Managing Control Samples and related record. Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device. Investigating out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data and log book related to testing activity. Responsible for reviewing the chromatographic data.Qualification & ExpeirencePost Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm 5-7 years in chemical & instrumental testing laboratory with exposure to GMP, GLP

ResponsibilitiesReview and maintain Master Batch Manufacturing Records and Master Batch Packing Records to ensure accuracy, regulatory compliance, and alignment with approved specifications and process related changes. Coordinate with Production, QC, and Regulatory Affairs for timely updates and approvals. Annual Product Quality Review (APQR) Prepare, compile, and review Annual Product Quality Reviews (APQRs) in line with regulatory expectations. Support identification of improvement opportunities and follow-up of CAPAs arising from APQR findings. cGMP Training Coordination Coordinate and monitor cGMP and quality-related training programs for site personnel. Maintain trainingschedules, records, and effectiveness assessments. Archival & Records Retention Manage the archival room and document storage systems for controlled and historical GMP documents. Ensure secure storage, easy retrieval, retention compliance, and protection against unauthorized access or damage. Support audits and inspections by ensuring availability of archived records.Qualification & ExperienceBachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. Experience 1–5 years of relevant experience in Pharma Quality Assurance / Documentation

ResponsibilitiesQuality system management Implement and maintain a local quality system applying primarily to SwissMedic-regulated activities related to the import and distribution of products and controlled substances Assure compliance with local regulations in Switzerland, international GDP / GMP requirements and the company Write SOPs and relevant documents, manage them in eDMS (electronic Document Management System) and support in implementation by training employees QA GMP, systems: GMP and process trainings, personal file maintenance Providing support to ensure inspection readiness and participation on internal audits and HA inspections QA POs executions in Fiori Product Quality Management Preparation of Market release of purchased or repacked products for Swiss Market: Str. 2 ZENTIVA JOB DESCRIPTIONEnsure completeness of batch documentation for batch release and request relevant documents form the suppliers or internal stakeholders, if necessary

Responsibilities Monitor performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence is accurate and complete. May be responsible for own assignments as project team member. This may include but not limited to taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables, generating study specific status reports for study teams, Sponsors and/or management, and attend project team meetings as required at the project level Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget. Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables Where assigned, produce accurate resourcing plans in conjunction with appropriate Project Team Members, including but not limited to facilitating appropriate resource identification and assignment, and monitoring resource needs throughout the project as needed.Qualification & ExperienceEducated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience.

Responsibilities  Support global regulatory lifecycle management activities across EU, US, and international markets  Contribute to regulatory strategy development for global and regional submissions  Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5)  Manage post-approval changes, variation submissions, and follow-up activities  Handle Health Authority queries and ensure timely responses  Provide submission management support including planning, coordination, and timeline tracking  Maintain accurate records in Regulatory Information Management (RIM) systems  Support safety-related regulatory activities such as aggregate reports and urgent safety updates  Assist with audit, compliance, and inspection readiness activitiesQualification & Experience Strong knowledge of EU & US regulatory procedures and post-approval requirements  Experience in global submission management and lifecycle maintenance  Understanding of regulatory documentation and compliance standards  Strong coordination and stakeholder management skills.  2 to 4 years of relevant experience Educational Qualification  B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy

Responsibilities Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines. Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault. Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs. Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions. Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics). Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications. Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities. Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management.Qualification & Experience Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field. Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD. Hands-on experience with Veeva Vault RIM and regulatory submission tools. Strong knowledge of EU regulatory processes (CTA, MAA, IDMP, lifecycle management).

ResponsibilitiesArtwork Management (all components) Understanding and operational efficiency of artwork management system.  Artwork requests to be raised with India specific annotations.  Comments received from overseas sites to be addressed and post peer review, approve final artwork files as per artwork approval checklist. Coordination with packaging coordinator, supply chain, BU/ Pricing / Legal team wherever required.  Support for QR code / serialization implementation as per business and regulatory needs.  Review and impact assessment of new India regulations relevant to labels if any. Ensure implementation as per timelines in coordination with local/ global stakeholders.  Support artwork developed for local partners as applicable.  Support labels of neighbouring markets e.g. Nepal as needed.  Prepare for audit of labeling activity if any and implement CAPAs if applicable.  Liaison closely with overseas manufacturing site for labels of 1st launch batch, exploring innovative options for early launch.  Ensure 100?herence to internal and external labelling requirements. Internal customers Marketing, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA External customers Local Health Authorities and other Government Agencies Qualification & ExpeirenceB. Pharm/ M. Sc 3-6 yrs Experience in India Artwork requirement and knowledge of D&C act for Artwork checklist. Should be conversant with Indian regulations in Artwork development.

ResponsibilitiesDispatch and line clearance activities. Review of executed BMR, BECR, and analytical raw data. Preparation of process validation protocols and monitoring of process validation activities. Preparation and revision of SOPs. Preparation of Annual Product Reviews (APR). Handling of cleaning validation activities. Initiation and coordination of deviations and change controls whenever required.